Report of a collaborative study for assessing the potency of hepatitis B vaccines.
A collaborative study was carried out to examine the suitability of a hepatitis B vaccine derived from plasma as an immunogenicity reference for vaccines produced by recombinant DNA technology in yeast. The use of a plasma derived vaccine as reference appeared satisfactory, although the use of homologous reference improved agreement in potency estimates. The use of a recombinant standard did not however improve agreement for a recombinant vaccine produced by a different manufacturer. The variation in the dilution of vaccine required to induce antibodies in 50% of test animals and in potency estimates varied widely between laboratories (25-fold and 10-fold respectively). However this was similar to the variation found in a previous collaborative study.
Ferguson
M
M
Department of Computing and Statistics, National Institute for Biological Standards and Control, Potters Bar, Herts, U.K.
Heath
A
A
Minor
P D
PD
D000818:Animals; D006510:Hepatitis B Antibodies / Q000032:analysis / Q000096:biosynthesis; D006515:Hepatitis B virus / Q000276:immunology*; D051379:Mice; D012015:Reference Standards; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000592:standards; D014761:Viral Hepatitis Vaccines / Q000592:standards*
D006510:Hepatitis B Antibodies; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines